U.S. patent application number 12/000422 was filed with the patent office on 2008-06-19 for endovalve.
Invention is credited to Mikolaj Styrc.
Application Number | 20080147183 12/000422 |
Document ID | / |
Family ID | 37908317 |
Filed Date | 2008-06-19 |
United States Patent
Application |
20080147183 |
Kind Code |
A1 |
Styrc; Mikolaj |
June 19, 2008 |
Endovalve
Abstract
The endovalve comprises an endoprosthesis deployable between a
contracted state and an expanded state. The endoprosthesis defines
an internal duct. The endovalve includes a valve placed in the
internal duct and movable between a closed configuration shutting
the duct and a release configuration leaving the duct open. The
endovalve has connection means between the valve and the
endoprosthesis. The connection means comprise at least one
intermediate connection member connected to the endoprosthesis and
including at least one region that is movable relative to the
endoprosthesis. The valve is fastened to the movable region.
Inventors: |
Styrc; Mikolaj; (Kopstal,
LU) |
Correspondence
Address: |
WENDEROTH, LIND & PONACK, L.L.P.
2033 K STREET N. W., SUITE 800
WASHINGTON
DC
20006-1021
US
|
Family ID: |
37908317 |
Appl. No.: |
12/000422 |
Filed: |
December 12, 2007 |
Current U.S.
Class: |
623/2.12 |
Current CPC
Class: |
A61F 2/2418 20130101;
A61F 2220/0075 20130101; A61F 2230/0078 20130101 |
Class at
Publication: |
623/2.12 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 14, 2006 |
FR |
06 10909 |
Claims
1. An endovalve of the type comprising: an endoprosthesis
deployable between a contracted state and an expanded state, the
endoprosthesis defining an internal duct; a valve placed in the
internal duct and movable between a closed configuration shutting
the internal duct and a release configuration leaving the internal
duct open; and connection means between the valve and the
endoprosthesis; wherein the connection means comprise at least one
intermediate connection member connected to the endoprosthesis and
including at least one region that is movable relative to the
endoprosthesis, the valve being fastened to the or to at least one
movable region.
2. An endovalve according to claim 1, wherein the endoprosthesis
has a side wall defining at least one transverse opening, opening
into the internal duct and to the outside of the endoprosthesis
through the side wall, the assembly formed by the intermediate
connection member and the valve being engaged in the transverse
opening.
3. An endovalve according to claim 2, wherein the assembly formed
by the valve and the intermediate connection member is movable
locally relative to the side wall over a stroke that is defined by
the transverse opening.
4. An endovalve according to claim 2, wherein the intermediate
connection member has an outside region placed outside the
endoprosthesis and an intermediate region connecting the or each
movable region via a transverse opening of the endoprosthesis.
5. An endovalve according to claim 1, wherein the intermediate
connection member is movable locally along its entire length
relative to the endoprosthesis.
6. An endovalve according to claim 1, wherein the intermediate
connection member is placed outside the endoprosthesis, the valve
being fastened to the intermediate connection member via at least
one transverse opening formed in the endoprosthesis along a line of
fastening.
7. An endovalve according to claim 6, wherein the intermediate
connection member is of a shape that is substantially complementary
to the shape of the line of fastening.
8. An endovalve according to claim 1, wherein the intermediate
connection member is a filamentary tie.
9. An endovalve according to claim 1, wherein the intermediate
connection member is a ribbon.
10. An endovalve according to claim 1, wherein the intermediate
connection member is a tubular sleeve placed around the
endoprosthesis.
Description
[0001] The present invention relates to an endovalve of the type
comprising: [0002] an endoprosthesis deployable between a
contracted state and an expanded state, the endoprosthesis defining
an internal duct; [0003] a valve placed in the internal duct and
movable between a closed configuration shutting the internal duct
and a release configuration leaving the internal duct open; and
[0004] connection means between the valve and the
endoprosthesis.
BACKGROUND OF THE INVENTION
[0005] Such endovalves are intended in particular to replace
defective native valves in the human heart.
[0006] An endovalve of the above-specified type is known that is
implanted as a replacement for a native valve by the endoluminal
approach. To do this, the endovalve is taken to its point of
implantation while in a contracted state, e.g. in a catheter. The
endovalve is then deployed in register with the native valve that
needs to be replaced, and becomes pressed against the wall defining
the native valve.
[0007] In order to ensure that the valve carried by the endovalve
operates properly, it is necessary for it to be fastened securely
to the endoprosthesis that constitutes the structure bearing
against the wall.
[0008] Consequently, it is known to stitch the valve in the
endoprosthesis so as to fasten it securely to the filaments
constituting the deployable trellis of the endoprosthesis. The
stitching is performed outside the human body, while the
endoprosthesis is in its expanded state, in a uniform
configuration.
[0009] Nevertheless, after the endoprosthesis has been implanted it
has a shape that depends on the morphology of the patient in which
it is implanted. Thus, if the configuration of the native valve
does not present a cross-section that is cylindrical, then the
endoprosthesis in its expanded state will occupy a section that
might be elliptical, or even triangular. Such shapes that are not
radially uniform create stresses on the valve fastened to the
trellis, thereby tending to damage the valve or to interfere with
its operation.
OBJECTS AND SUMMARY OF THE INVENTION
[0010] An object of the invention is thus to provide an endovalve
capable of being implanted in satisfactory manner in patients
presenting a variety of morphologies, without harming the
reliability of its operation.
[0011] To this end, the invention provides an endovalve of the
above-specified type, wherein the connection means comprise at
least one intermediate connection member connected to the
endoprosthesis and including at least one region that is movable
relative to the endoprosthesis, the valve being fastened to the or
to at least one movable region.
[0012] The endovalve of the invention may include one or more of
the following characteristics taken in isolation or in any
technically feasible combination: [0013] the endoprosthesis has a
side wall defining at least one transverse opening into the
internal duct and to the outside of the endoprosthesis through the
side wall, the assembly formed by the intermediate connection
member and the valve being engaged in the transverse opening;
[0014] the assembly formed by the valve and the intermediate
connection member is movable locally relative to the side wall over
a stroke that is defined by the transverse opening; [0015] the
intermediate connection member has an outside region placed outside
the endoprosthesis and an intermediate region connecting the or
each movable region via a transverse opening of the endoprosthesis;
[0016] the intermediate connection member is movable locally along
its entire length relative to the endoprosthesis; [0017] the
intermediate connection member is placed outside the
endoprosthesis, the valve being fastened to the intermediate
connection member via at least one transverse opening formed in the
endoprosthesis along a line of fastening; [0018] the intermediate
connection member is of a shape that is substantially complementary
to the shape of the line of fastening; [0019] the intermediate
connection member is a filamentary tie; [0020] the intermediate
connection member is a ribbon; and [0021] the intermediate
connection member is a tubular sleeve placed around the
endoprosthesis.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] The invention can be better understood on reading the
following description given purely by way of example and made with
reference to the accompanying drawings, in which:
[0023] FIG. 1 is a face view of a first endovalve of the
invention;
[0024] FIG. 2 is a section view on horizontal cross-section plane
II showing the endovalve of FIG. 1;
[0025] FIG. 3 is a view analogous to FIG. 1 showing a second
endovalve of the invention;
[0026] FIG. 4 is a view analogous to FIG. 2 showing the second
endovalve of the invention;
[0027] FIG. 5 shows two examples of intermediate fastener ribbons
for the second valve of the invention;
[0028] FIG. 6 is a view analogous to FIG. 1 showing a third
endovalve of the invention; and
[0029] FIG. 7 is a view analogous to FIG. 2 showing a third
endovalve of the invention.
MORE DETAILED DESCRIPTION
[0030] The first endovalve 10 of the invention, shown in FIGS. 1
and 2, is for replacing a defective native heart valve via the
endoluminal approach.
[0031] The endovalve 10 comprises a tubular endoprosthesis 12, a
valve 14 placed in the endoprosthesis 12, and intermediate
connection means 16 between the endoprosthesis 12 and the valve
14.
[0032] The tubular endoprosthesis 12 is made up of a frame
constituted by a tubular trellis 18 that possesses spring
properties. The trellis 18 is obtained by braiding at least one
filament of stainless steel, of a shape memory alloy, or of a
polymer. In a variant, the trellis is obtained by using a laser to
cut it out from a tube.
[0033] The trellis 18 comprises a plurality of filamentary segments
20 that cross over one another and define lozenge-shaped transverse
openings 22.
[0034] The trellis 18 defines an inside surface 24 defining an
internal duct 26 through which blood flows, and an outside surface
28 for pressing against the wall of a blood vessel, in register
with the defective native valve.
[0035] The transverse openings 22 open out into the inside surface
24 and into the outside surface 28.
[0036] The metal trellis 18 of the endoprosthesis 12 is deployable
between a contracted state in which it presents a small diameter
and an expanded state, constituting its rest state, in which it
presents a large diameter.
[0037] In the example shown in FIG. 1, the trellis 18 is
spontaneously deployable between its contracted state and its
expanded state. In a variant, a balloon is used for deploying
it.
[0038] The valve 14 is made for example on the basis of a native
valve from an animal such as a pig. In a variant, it is made on the
basis of natural or synthetic fabric.
[0039] It comprises a tubular base 30 extended upwards by three
duct-closing flaps 32A, 32B, and 32C.
[0040] The base 30 presents an outside surface that is
substantially complementary to the inside surface 24 of the
endoprosthesis 12, against which it is applied.
[0041] In the example shown in FIG. 2, the flaps 32A, 32B, and 32C
are made integrally with the base 30 which they extend upwards.
[0042] The flaps 32A, 32B, and 32C are distributed around the axis
X-X' of the duct 26. Each flap 32A, 32B, and 32C thus occupies an
angular sector of about 120.degree. about the axis X-X'.
[0043] Each flap 32A, 32B, and 32C is in the form of a pouch-shaped
membrane 34 extending facing the portion of the inside surface 24.
Each flap 32A, 32B, and 32C is defined outwards and downwards by a
substantially U-shaped fastener line 36, and upwards by a free edge
38 that is movable in the duct 26.
[0044] The fastener line 36 extends substantially over the inside
surface 24 of the endoprosthesis 12 to two top ends 40 forming the
side ends of the free edge 38. Each top end 40 of a flap 32A, 32B,
and 32C is common between two adjacent flaps 32A, 32B, and 32C.
[0045] As explained below, the fastener lines 36 are stitched
exclusively onto intermediate connection means 16 and not onto the
trellis 18 of the endoprosthesis 12.
[0046] The free edge 38 extends substantially horizontally within
the internal duct 26 between the top ends 40.
[0047] The free edges 38 and the pouches 34 can be moved under the
effect of the pressure of blood in the internal duct 26, between a
release configuration for opening the duct 26 (not shown) and a
closed configuration for shutting the duct 26, as shown in FIG.
2.
[0048] In the release configuration, the pouches 34 are pressed
against the inside surface 24 of the endoprosthesis 12. The free
edges 38 then extend the surface 24 and are spaced apart from one
another.
[0049] The distance between each free edge 38 and the axis X-X' is
then at a maximum. The area occupied by the flaps 32A, 32B, and 32C
in the duct 26 is then at a minimum to allow blood to pass
through.
[0050] In the closed configuration, the pouches 34 are deployed
inside the duct 26. The free edges 38 are situated close to the
axis X-X'. The free edge 38 of each flap 32A, 32B, and 32C is
pressed over substantially its entire length against the free edges
38 of the adjacent flaps 32B, 32C, and 32A.
[0051] In this configuration, the pouches 34 occupy a maximum area
within the duct 26, and blood is substantially prevented from
passing along the duct 26.
[0052] According to the invention, the connection means 16 between
the valve 14 and the endoprosthesis 12 are formed by intermediate
connection members connected to the endoprosthesis 12, but
including at least one region that is displaceable relative to the
endoprosthesis 12.
[0053] In the first endovalve 10 of the invention, the connection
means 16 are formed by a top connection filament 50 for fastening
to the flaps 32A, 32B, and 32C, and by a bottom connection filament
52 for fastening to the base 30.
[0054] The filaments 50, 52 are interlaced with the trellis 18 of
the endoprosthesis 12 between the inside surface 24 and the outside
surface 28. The filaments 50, 52 thus pass successively inside and
outside the filamentary segments 20 constituting the trellis 18 by
passing through the openings 22.
[0055] The filaments 50, 52 are thus connected to the
endoprosthesis in that they can move together with the
endoprosthesis 12 when the endoprosthesis 12 is moved over a long
distance.
[0056] Nevertheless, the filaments 50, 52 are locally movable over
their entire length relative to the endoprosthesis 12, over a
stroke that is defined by the size of each opening 22 in which the
filament 50, 52 is engaged.
[0057] Each filament 50, 52 defines a plurality of outside regions
54 situated on the outside of the endoprosthesis 12, a plurality of
inside fastener regions 56 placed inside the internal duct 26, and
a plurality of intermediate regions 58, each intermediate region 58
connecting a region 54 to a region 56 via a transverse hole 22.
[0058] The top connection filament 50 presents three U-shaped spans
60 extending respectively facing the fastener lines 36 of each flap
32A, 32B, and 32C.
[0059] The flaps 32A, 32B, and 32C are stitched to the inside
fastener regions 56. The flaps 32A, 32B, and 32C and the filament
50 thus form a single assembly engaged in a plurality of transverse
openings 22.
[0060] Similarly, the bottom connection filament 52 extends along
the bottom edge of the base 30 around a circumference of the inside
surface 24 about the axis X-X'. The base 30 of the valve 14 is
stitched to the inside fastener regions 56 of the bottom connection
filament 52, along said circumference.
[0061] The valve 14 is thus fastened overall relative to the
tubular endoprosthesis 12 so as to be moved together with the
endoprosthesis 12 by co-operation between the trellis 18 and the
assembly constituted by the valve 14 together with the intermediate
connection filaments 50, 52. The assembly formed by the valve 14
and the filaments 50, 52 is also movable locally relative to the
endoprosthesis 12 in the openings 22, following a stroke that is
defined by the size of each opening 22.
[0062] The operation of the first endovalve 10 of the invention is
described below.
[0063] Initially, during fabrication of the endovalve 10, the
filaments 50, 52 are engaged in the trellis 18 of the
endoprosthesis 12 to form three respective U-shaped spans 60 around
the axis X-X', and to extend along a bottom circumference of the
trellis 18. The valve 14 is then inserted into the duct 26 and is
stitched to the inside fastener regions 56 of the filaments 50,
52.
[0064] The endoprosthesis 12 is then retracted into its contracted
state and is maintained in this state by release means (not shown)
for releasing the endovalve 10 in the organism, and constituted for
example by an outer sheath or by a filamentary release system as
described in application FR-A-2 863 160 in the name of the
Applicant.
[0065] Thereafter, the release means transporting the endovalve 10
are inserted into the patient and taken to the implantation site,
e.g. using an endoluminal approach.
[0066] When the endovalve 10 is situated in register with its
implantation site, in the vicinity of the native valve, the release
means are operated to cause the endovalve 10 to pass from its
contracted state to its expanded state. The outside surface 28 of
the endoprosthesis 12 is then pressed against the wall of a
blood-flow duct. The endoprosthesis 12 then presents a
cross-section that is substantially complementary to the section of
the duct in which it is applied.
[0067] Nevertheless, even if the trellis 18 does not deploy
uniformly around the axis X-X', i.e. if some of the transverse
openings 22 of the trellis 18 are more deformed than others, any
stresses on the valve 14 are released by local movements of the
filaments 50, 52 and of the valve 14 relative to the trellis 18 in
the openings 22. The valve 14 thus occupies a relaxed state,
thereby increasing its reliability in operation over time.
[0068] Furthermore, since the valve 14 is fastened solely by means
of the intermediate connection filaments 50, 52, without being
fastened directly to the filamentary segments 20 constituting the
trellis 18, the deployment of the trellis 18 on the endoprosthesis
12 passing from the contracted state to the expanded state is not
impeded by the presence of the valve 14, thereby making it easier
to release the endoprosthesis 12.
[0069] In a variant, the filaments 50, 52 are placed around the
outside surface 28 of the endoprosthesis 12. The filaments 50, 52
are fastened to the trellis 18 at certain points, e.g. at least
three points around the periphery.
[0070] The valve 14 is fastened to the filaments 50, 52 via the
transverse openings 22 in free regions of the filaments 50, 52 that
are situated between the points where they are fastened to the
trellis 18.
[0071] In another variant, the valve 14 has a tubular wall
surrounding and carrying the flaps 32A, 32B, and 32C. The tubular
wall is pressed against the inside surface 24.
[0072] Under such circumstances, the top filament 50 presents an
outline that is substantially circular, like that of the bottom
filament 52. The tubular wall of the valve 14 is then fastened to
the filaments 50, 52.
[0073] The second endovalve 70 of the invention differs from the
first endovalve 10 in that the connection means 16 comprise
intermediate members in the form of fabric ribbons 72, 74 of shapes
substantially complementary to the shapes of the lines of stitching
36 of the valve 14. Thus, the top fastener ribbon 72 presents three
U-shaped spans 60 that are stitched to one another via their top
ends. The bottom ribbon 74 presents a ring shape.
[0074] By way of example, the ribbons 72, 74 are made using a
biologically compatible fabric that is woven or knitted, such as
Dacron.RTM..
[0075] The ribbons 72, 74 are pressed against the outside surface
28 of the endoprosthesis 12, outside the internal duct 26 and they
are connected to the valve 14 by stitches 76 made through the
openings 22.
[0076] The operation of this second endovalve 70 is substantially
analogous to that of the first endovalve 10.
[0077] In the variant shown in part in FIG. 5, the fastener ribbon
72A comprises three independent spans 60A, 60B, and 60C that are
not connected to one another. Each span 60A, 60B, and 60C is
fastened respectively to the fastener line 36 of a respective flap
32A, 32B, and 32C.
[0078] The third endovalve 80 of the invention, shown in FIGS. 6
and 7 differs from the second endovalve 70 in that the intermediate
connection member of the connection means 16 is formed by a single
sleeve 82 of fabric engaged around the outside surface 28 of the
endoprosthesis 12.
[0079] The sleeve 82 presents a height that is substantially equal
to the height of the valve 14. Stitches 84 secure the flaps 32A,
32B, and 32C and the base 30 securely to the sleeve 82 via the
transverse openings 22.
[0080] The operation of this third endovalve 80 of the invention is
analogous to that of the first endovalve 10 or of the second
endovalve 70.
[0081] In a variant shown in dashed lines in FIG. 6, the sleeve 82
defines three U-shaped notches 120, each extending in register with
a respective flap 32A, 32B, and 32C over the fastener lines 36 of
the flaps 32A, 32B, and 32C. The notches 120 open out upwardly into
the top edge of the sleeve 82, so as to allow blood to move the
flaps 32A, 32B, and 32C from their release configuration pressed
against the inside surface 24 towards their closed configuration
shutting the duct 26.
[0082] In a variant shown in dashed lines in FIG. 1, the top
filament 50 is provided with a loop 100 projecting outwards from
the surface 28 so as to enable the endovalve 10 to be recovered by
pulling on the filament 50 as described in French patent
application 06/02932 in the name of the Applicant.
* * * * *